LIST OF APPROVED DRUG FROM 01.01.2010 TO 31.8.2010 S.NO PRODUCT NAME Ferrous ascorbate 100mg + Folic acid 1.

1 mg tablet and Omega-3-fatty acid 200mg capsules combikit Sphaeranthus Indicus Extract Tablets 700mg Febuxostat 40mg Additional Strength Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system) Buclizine Hcl 25mg Tablet (Additional Indication) INDICATION DATE OF APPROVAL

For iron, folic acid & omega-3-fatty acid deficiency

08/01/2010

2 3 4

For the management of psoriasis. Same As approved For the treatment of macular edema following branch retinal vein occlusion (CRVO)

08/01/2010 16/01/2010 16/01/2010

7 8 9 10

11

For the Symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other than predominantly Pemetrexed Disodium squamous cell histology in patients whose disease has 500mg/100mg Powder for not progressed immediately following platinum-based Injection (additional indication) chemotherapy. First line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel. Levobetaxolol HCl Opthalmic For lowering of intraoccular pressure in patients with Suspension 0.5% chronic open-angle glaucoma or occular hypertension. Sarpogrelate Hydrochloride For the improvement of ischemic symptoms including film coated Tablets 100mg ulcer, associated with chronic arterial occlusion. Propanol 1-ol 18gm + Ethanol For hygenic and surgical hand disinfection 100% 45gm/100ml solution Aliskiren 150/160mg + For the treatment of hypertension Valsartan 300/320mg tablets For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute Piroxicam 20mg tab& musculoskeletal disorders, pain after operative Paracetamol 500mg tab intervetion and following trauma, chronic condition combikit like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes.

16/01/2010

16/01/2010

16/01/2010 16/01/2010 18/01/2010 19/01/2010

19/01/2010

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13

14 15 16 17 18

19

20 21 22

Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dl-alpha-tocopherol 163-225mg + glycerol Total parenteral nutrition following major abdominal, (anhydrous) 25gm + Egg major thoracic or major urological surgery lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. In combination with other anti retroviral agents for the treatment of human immunodeficiency virus (HIV-1) Raltegravir (as Potassium) film infection in treatment experienced patients with coated Tablets 400mg evidence of HIV-1 replication despite ongoing retroviral therapy. Deflazacort Tablet 18mg Same as approved (Additional Strength) Pregabalin SR Tablet 75mg Same as approved (Additional Strength) For the prevention of venous thromboembolism in Rivaroxaban film coated patients (VTE) in adult patients undergoing hip or knee Tablets 10mg replacement surgery. Cinnarizine 20mg + For the treatment of vertigo Dimenhydrinate 40mg tablets Indicated in the treatment of cutaneous and Lipid Based Amphotericin-B mucocutaneous mycotic infections caused by candida Gel 0.1% (Monilia) species. Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, Same as approved 25.5mg/ml (Additional Strength) Milnacipran Hcl 12.5mg (Addl. Same as approved Strength) Ropinirole 6mg ER Tablets Same as approved (Addl. Strength) Coseal Surgical Sealent 2/4/8ml (1) Enforcement of suture and staple lines in lung (Addl. Indication) resection procedures. (2)Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation. (3)Patients undergoing laparotomy or laproscopic abdomino-pelvic surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post

19/01/2010

27/01/2010

30/01/2010 30/01/2010 30/01/2010 03/02/2010 05/02/2010

06/02/2010

06/02/2010 06/02/2010 06/02/2010

surgical adhesion formation.

23

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Pregabalin SR 75/150/300mg + For the treatment of adult patients with peripheral Methylcobalamin 1500mcg neuropathy tablets For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal Ivabradine Hcl Tablets 5/7.5mg sinus rhythm, indicated in combination with beta(Additional Indication) blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60bpm. Paracetamol Solution for Infusion (10mg/ml) in 50ml Same as approved (Additional Packsize) Ketorolac Tromethamine Indicated for the treatment of pain and inflammation Ophthalmic Solution 0.45% following cataract surgery. In combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia of adults and children. It has Cytarabine Injection 100mg also been found useful in the treatment of acute Additional Packsize (20ml) lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia. Olopatadine Hcl Nasal Spray For the relief of the symptoms of seasonal allergic 0.6% w/w (Additional rhinitis in patients 6 years of age and older. Indication) Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate Replacement of extracellular fluid losses in case of 0.37gm + Magnesium chloride isotonic dehydration, especially if acidosis is being hexahydrate 0.20gm + Sodium imminent or present acetate trihydrate 3.27gm + Lmalic acid 0.67gm in 1000ml solution for infusion

09/02/2010

10/02/2010

10/02/2010 10/02/2010

10/02/2010

10/02/2010

11/02/2010

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32 33 34 35 36

Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier. Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets Celecoxib Mouth Dissolving Tablet 50/100/200 mg Propofol 2% w/v Injection (additionalStrength) Spironolactone 25mg + Furosemide 20mg tablets Olopatadine5mg + Ambroxol30mg tablets Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules Calcium acetate 435mg + Magnesium carbonate 235mg tablets Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension. Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo

As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement. For the treatment of patients with acute painful musculoskeletal conditions For the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections For the Treatment of Osteoarthritis and Rheumatoid Arthritis Same as Approved For treatment of resistant oedema associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis For the management of cough in adult patients only For the treaetment of painful diabetic neuropathy in adults only

11/02/2010

12/02/2010

12/02/2010 25/02/2010 27/02/2010 05/03/2010 05/03/2010

37

05/03/2010

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42 43

For the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc. For the treatment in adults patients with dandruff/seborrheic dermatitis of the scalp For the Treatment of respiratory tract infections, Faropenam Sodium Extended urinary tract infection, skin and skin structure Release Tablet 225/300/450 mg infections and gynaecological infections Amlodipine5mg + Ramipril10mg/5mg Tablets For the treatment of hypertension only (additional strength) For the treatment of Bronchial Asthma and COPD in Doxofylline MR Tablet 650 mg Adults

05/03/2010

05/03/2010

05/03/2010 08/03/2010

10/03/2010 11/03/2010

44

45

Lidocaine7.5mg + Prilocaine2.5mg per acutation spray Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets Miglitol 25 mg + Metformin 500mg tablets Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules Citicholine 500mg + Piracetam 400mg Tablets Diclofenac 50mg + Chlorzoxazone500mg Tablets Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets Etoricoxib 1%+ Menthol 5% Spray

For the treatment of adult male patients with premature ejaculation For the treatment of the sign and symptoms of idiopathic parkinsons disease For the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication) Additional Strength For the prophylaxis of migraine For the treatment of acute stroke For the treatment of acute inflammation conditions associated with spasm in adults only For the treatment of diabetic neuropathy in adults

12/03/2010

13/03/2010

46 47 48 49 50

16/03/2010 16/03/2010 16/03/2010 16/03/2010 16/03/2010

51

16/03/2010

52 53 54 55

For the topical treatment of acute musculoskeletal pain

16/03/2010 17/03/2010 17/03/2010 20/03/2010

56

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For the treatment of patients suffering from non-ulcer Pantoprazole 40mg + dyspepsia (NUD) or gasteroesophageal reflux disease Cinitapride (ER) 3mg Capsules (GERD) Atorvastatin 20mg + Ramipril Additional higher strength 2.5mg/5mg Capsules Lamotrigine Orodispersible Tablet 12.5 mg(additional Same as Approved strength) Trabectedin powder for Conc. In combination with pegylated liposomal doxorubicin, solution for infusion it is indicated for the treatment of patients with relapsed (Additional Indication) platinum- sensitive ovarian cancer Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Additional higher strength Tablets For the treatment of rheumatoid arthritis, osteoarthritis, Diclofenac sodium SR Tablet ankylosing spondilytis,gout,painful post perative pain 150 mg following dental surgery etc.

20/03/2010

23/03/2010

26/03/2010

59 60

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62 63 64 65 66

67

68 69 70

Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg Same as Approved (additonal strength) Lidocaine 2.5% w/w+Prilocaine Additional higher Strength 2.5% w/w Gel 1. For the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDl-cholesterol) and in patients with primary hypercholesterolemia Nicotinic Acid and Laropiprant (heterozygous familial and nonModified Release Tablets: familial). Nicotinic Acid.........1000 2. In combination with HMGmg CoA reductase inhibitors (statins), when cholesterol lowering effect of HMG-CoA reductase inhibitor Laropiprant...........20mg monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet or other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy. Pantoprazole Mouth Dissolving For the treatment of gastric ulcer, duodenal ulcer & Tablet 20/40 mg gastroesophageal reflux disease (GERD). Praziquntel 175mg + Pyrantel For the treatment of mixed infections with roundworms 504mg + Febental 525mg and tapeworms in dogs Tablets Difluprednate Opthalmic For the treatment of inflammation and pain associated Emulsion 0.05% w/v with ocular surgery. Tolperisone Hcl SR 450mg For the relief of painful muscle spasms of the skeletal Tablets muscualture. S(-)Metoprolol 25mg/50mg For the treatment of patients with both essential (ER) + Atorvastatin (IR)10mg hypertension and hypercholesterolemia tablets Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) For secondary prophylaxis of ischemic heart disease in 75mg/150mg + Metoprolol (ER patients where use of such combinations in appropriate tablets) 25mg Capsules Lamotrigine 25mg Modified Same as Approved Release Tablet (Addl. Strength) Imatinib Mesylate 100/400mg Adjuvant treatment of adult patients following Tablets (Addl. Indication) resection of gastro-intestinal stromal tumours (GIST) Azithromycin SR Granules for Same as Approved Oral Suspension 1gm (Addl.

26/03/2010 26/03/2010

26/03/2010

30/03/2010 30/03/2010 30/03/2010 30/03/2010 04/01/2010

05/04/2010

05/04/2010 05/04/2010 05/04/2010

Strength) Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication) Ibuprofen 400mg + Chlorzoxazone 500mg Tablets Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets For the treatment of other dyslipidemias: (a) Fredrickson Types III and V.(b) Associated with diabetes.(C) Associated with xanthomata. For the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only For the treatment of bronchial asthma in adults To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > 50mm or left ventricular ejection fraction [LVEF] < 40%), who are in sinus rhythm or who will be cardioverted. For the treatment of chronic pain. To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: 13/04/2010 Patients with unstable angina (UA) or non-STelevation myocardial infarction (NSTEMI). Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. 77 78 79 Tofisopam uncoated tablet JP... For the treatment of anxiety and depression. 50/100mg Zotepine tablet ....25/50/100mg For the treatment of schizophrenia To improve wakefulness in patients with excessive Armodafinil uncoated sleepiness associated with treated obstructive sleep tablet ..50/150/250mg apnea (OSA), shift work sleep disorder (SWD) or narcolepsy. Indacaterol ( as Maleate ) For maintenance bronchodilator treatment of airflow Inhalation Powder Hard obstruction in adult patients with chronic obstructive Capsules .. ...150/300mcg pulmonary disease (COPD). 13/04/2010 15/04/2010 23/04/2010

71

05/04/2010

72 73

07/04/2010 07/04/2010

74

Dronedarone( as Hydrochloride) film coated tablet .... 400 mg.

08/04/2010

75

Dosulepin Hcl Tablet 25mg/75mg (Additional Indication)

08/04/2010

76

Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.

80

24/04/2010

81 82 83

Ranolazine ER Tablets 750mg (Additional Strength) Tacrolimus Capsules 3mg (Additional Strength) Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets

Same as Approved Same as approved For the treatment of patients with typhoid fever and urinary tract infection in adults

24/04/2010 24/04/2010 26/04/2010

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For symptomatic relief of dermatological condition Liquid paraffin 6% + White soft associated with dry skin including atopic dermatitis, paraffin 15%w/v Cream eczema, pruritus, ichthyosis, xerosis, psoriasis For the short term treatment of acutely decompensated Levosimendan Injection chronic heart failure (ADHF) in situations where 2.5mg / ml conventional therapy is not sufficient and in cases where ionotropic support is considered appropriate. As an adjuvant treatment in painful spasms associated Thiocholchicoside SR Tablet 16 with degenerative vertebral disorders and vertebral 31/04/2010 mg static problems, torticollis dorsal pain, low back pain, traumatological and neurological disorders. Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg For the treatment essential hypertension tablet one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Additional strength Sulphadoxine IP 500mg + Pyrimethamine IP 25mg In combination with letrozole for the treatment of postmenopausal women with hormone receptor Lapatinib Ditosylate Tablets positive metastatic breast cancer that overexpresses the 250mg (addl. Indication) HER2 receptor for whom hormonal therapy is indicated. Pentosan polysulfate Sodium For the relief of bladder pain or discomfort associated Cpasules 100mg with interstitial cystitis. Indapamide (SR) 1.5mg/1.5mg For the treatment of hypertension not controlled with +Nebivolol 2.5mg/5mg tablet monotherapy Cinitapride (ER) 3mg + For the treatment of gastirc ulcer,gastroesophageal Omeprazole (EC) 20mg reflux disease(GERD) & Dyspepsia not responding to Capsules omeprazole alone For the treatment of elevated intraocular pressure in Timolol Maleate Long Acting patient with ocular hypertension or open angle Ophthalamic Solution 5mg/ml glaucoma.

29/04/2010

30/04/2010

05/04/2010

05/04/2010

10/05/2010

11/05/2010 12/05/2010 12/05/2010

14/05/2010

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98 99 100 101 102

103

For the prevention of cardiovascular morbidity and mortality in patient 55 years older at high risk of cardiovascular disease Dexketoprofen Trometamol For the treatment of acute low back pain and other 25mg + Thiocolchicoside 4mg musculoskeletal painful & inflammatory conditions in tablets adult patients For the treatment of Gastric ulcers and for amelioration Troxipide film coated Tablets of gastric mucosal lesions (erosion, hemorrhage, 50mg /100mg redness and edema) in the diseases such as acute gastritis, acute exacerbation stage of chronic gastritis. For the treatment of pulmonary arterial hypertension Ambrisentan film coated (WHO Group I) in patients with WHO class II or III Tablets 5 mg / 10mg symptoms to improve exercise capacity and delay clinical worsening. Risk reduction of MI stroke and arterial Rosuvastatin Calcium evascularisation procedure in patients without clinically Tablet(Additional Indication) evident CHD but with multiple risk factor Paracetamol SR 1000mg For symptomatic treatment of pain and fever Bilayered tablet For Prophylaxis of transplant rejection in adult kidney Tacrolimus PR Caps 0.5/1/5 mg or liver allograft rejection Rizatriptan Benzoate orally disintegrating tablet 10 Same as Already approved mg(Additional Dosage Form) Ramipril 1.25/ 2.5/5/10 For the treatment ofnon-diabetic overt glomerular or mg(Additional Indication) incipient nephropathy Use in patients with type-2 diabetes mellitus who are Exenatide Inj. (Additional using a thiazolidinedione alone or in combination with Indication) metformibn but have not achieved adequate glycemic control For the treatment of Telmisartan tablet 20/40/80 mg(Additional indication) "Adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment."

14/05/2010

20/05/2010

20/05/2010

24/05/2010

24/05/2010 24/05/2010 24/05/2010 24/05/2010 24/05/2010

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Temozolomide lyophilised powder 100mg / vial

24/05/2010 Children from the age of three years, adolescents and Adult patients with malignant giloma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

105

Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Prefilled syrings

For the maintenance treatment of asthma and for the treatment of COPD associated with chronic bronchitis

25/05/2010

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For filling any medium sized depression of the skin via mid dermis injection as well as for lip definition. The presence of lidocaine is meant to reduce the patients pain during the treatment Aceclofenac 1% w/w + For the treatment of acute painful inflammatory Menthol 5% Spray conditions in adults only Metformin SR 500mg/500mg + As 3rd line treatment of type II diabetes mellitus when GliclazideSR 60mg/30mg + diet, exercise and the single agents and the second line Pioglitazone 15mg/15mg therapy with two drugs do not result in adequate tablets glycemic control 3 tablets of artesunate 100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of Additional strength Pyrimethamine 25mg + Sulphadoxine 500mg combipack Calcium carbonate 600mg To relive the uncomfortable symptoms of acid +Simethicone 80mg Chewable indigestion, heart burn, gas or sour stomach tablet Activated Dimethicone 50mg + For treatment of symptoms of hyperacidity (e.g. Magnesium Hydroxide 250mg+ heartburn, epigastric discomfort, or their equivalents) Dried Aluminium that are often associated with dyspepsia, peptic ulcers, Hydroxide250 mg + Sorbitol gastritis, peptic esophagitis and indicated for relief of (70%)1.25 gm /5ml Solution flatulence Aspirin 75mg + Simvastatin For secondary prevention of coronory heart 10mg/20mg + Lisinopril disease/stroke in patients where use of such 5mg/10mg + Atenolol combination is appropriate 25mg/50mg Tablets For gastric ulcers, improvement of gastric mucosal Irsogladine Maleate Tablet lesion (erosion, hemorrhage, redness and edema) 2mg /4mg caused by acute gastritis and acute exacerbation stage of chronic gastritis. Lacosamide film coated tablet As an adjunctive treatment of partial onset seizures in 50mg /100mg /150mg /200mg patients > 17 years of age. Carmustine for inj. 100 mg Indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:

28/05/2010

28/05/2010

28/05/2010

28/05/2010

28/05/2010

28/05/2010

01/06/2010

05/06/2010

10/06/2010 10/06/2010

1.Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. 2.Multiple myelomain combination with prednisone. 3.Hodgkins Diseaseas secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. 4.Non-Hodgkins lymphomasas secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy. Monteleukast Sodium Tablet 10mg; Monteleukast Sodium For the relief of symptoms of seasonal allergic rhinitis 4/5mg Chewable Tablet; in adults and pediatric patients 2 years of age and older. Monteleukast Sodium Oral granule(Additional Indication) For the prevention and treatment of gastrointestinal Ramosetron Dispersible Tablet symptoms(nausea and vomitting) associated with 0.1 mg ematogenic cancer chemotherapy Amitraz 2%w/v pour on For the control of ticks on cattle and ostriches solution For treatment of acute and chronic pain ,i.e, for painful increased muscle tone of the posture and motor Flupirtine Maleate Capsules muscles, primary headache, 100mg tumor pain, dysmenorrhea and pain after traumatologic / orthopaedic operations and injuries. Lidocaine Patch 350mg (Additional Pack Size) For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

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120 121 122

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Oseltamivir Phosphate In the treatment of children 6 to 12 months of age (Additional indication) during a pandemic influenza outbreak. Methylcobalamin 1500mcg +Folic acid 0.7mg For the treatment of diabetic neuropathy in adults +Niacinamide 12mg injection Methylcobalamin 1500mcg +Pyridoxine 100mg For the treatment of diabetic neuropathy in adults +Nicotinamide 100mg injection 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg For the treatment of HIV infection in adults & 2 tablet of Nevirapine 200mg combipack

23/06/2010

23/06/2010

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Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic For the treatment of vitamin deficiency states in adults calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule Ramipril MR Capsules 2.5/5 Same As Approved 03/07/10 mg (Additional Strength) (i) Use of Sitagliptin Phosphate in combination with Metformin and a PPAR agonist as an adjunct to diet & Sitagliptin Phosphate 25/50/100 exercise in adult patients with type-2 Diabetes mellitus mg Tablet (Additional who are inadequately controlled on combination 03/07/10 Indication) therapy with Metformin and a PPAR agonist. (ii) Use of Sitagliptin Phosphate in combination with insulin, alone or in combination with Metformin. As monotherapy for maintenance treatment in patients Erlotinib HCl 25/100 mg Tablet with locally advanced or metastatic non-small cell lung 03/07/10 (Additional Indication) cancer with stable disease after 4 cycles of standard platinum based first line chemotherapy. Gemcitabine HCl injection Same as Approved 03/07/10 2gm/vial (Additional Strength) Etizolam 0.25 mg tablet Same As Approved 03/07/10 (Additional Strength) Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w For the topical treatment of acute musculoskeletal pain 06/07/10 +Menthol 5%w/w +Methyl Salicylate 10%w/w (12.5mg) Cefuroxime Sodium For the treatment of mild to moderate lower respiratory 750/1500mg +Sulbactam 06/07/10 tract infection Sodium 375/750mg

23/06/2010

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139 140 141 142 143

For the temporary relief of burning and irritation due to dryness of the eye and for use as a protection against HPMC 0.3% +Dextran 0.1% + further irritation. For the temporary relief of discomfort 06/07/10 Glycerin 0.2% due to minorirritations of the eyes or to exposure to wind or sun Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 mcg+Nicotinamlide IP100 For Mineral & Vitamins deficiency states in adult 06/07/10 mg+Pyridoxine 3mg +Selenius patients Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w For short term treatment of chronic wounds including 06/07/10 +CMC 1.74%w/w +Allantoin stage III & IV pressure sores, leg ulcers 0.5%w/w +Benzyl alcohol 0.5%w/w. Clonazepam IR 0.5mg/0.5mg+ For the treatment of patients with co-morbid depression 08/07/10 Paroxetine CR 12.5/25mg and axiety For the treatment of chronic and accelerated phase Philadelphia chromosome positive chronic Nilotinib Capsules 200mg myelogenous leukemia (CML) in adult patients 10/07/10 resistant to or intolerant to prior therapy that included imatinib. Treatment of infection caused by susceptible bacteria for the following indication as in neonates and infants (below 3 months of age) 1. Lower respiratory tract Imipenem 50mg + Clistatin infections 2. Urinary tract infections 3. Intra-abdominal 14/07/10 50mg infections 4. Bacterial septicemia 5. bone and joint infections 6. Skin and Skin structure infections 7. Bacterial endocarditis Lidocaine Lozenges 100mg Same as Approved 15/07/10 (Additional Strength) Metoprolol succinate ER 25/50 For the treatment of essential hypertension 16/07/10 mg+Telmisartan 20/40mg Etodolac 300/300mg For the treatment of patients with acute painful 19/07/10 +Thiocolchicoside 4/8mg musculoskeletal conditions Celecoxib 100/200mg For the treatment of adult patients with osteoarthritis of 19/07/10 +Diacerein 50/50mg knee and/or hip joints Metoprolol succinate ER For the treatment of essential hypertension 19/07/10 25mg+50mg + Olmesartan

20/20mg 1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg (Each Copack contains :- 1 capsule of For the treatment of HIV infections in adults Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of Tenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg) Gliclazide 40/80mg+Metformin Additional strength 500mg+Pioglitazone15mg Lidocaine HCl Ophthalmic Indicated for ocular surface anaesthesia during Sterile Gel 35 mg/ml ophthalmologic procedures. For the treatment of dysuria associated with benign Naftopidil Tablets 25/50/75mg prostratic hyperplasia. A) FDC is indicated as triple combination therapy with a PPARy agonist (i.e a thiazolidinedione) as an adjunct to diet and exercise in patients inadequtely controlled Metformin on their maximal tolerated dose of metfomin and a 500/850/1000mg+Sitagliptin PPARy agonist. B) FDC is also indicated as add-on to Phosphate 50/50/50mg insulin(i.e triple combination therapy) as an adjucnjt to (Additional Indication) diet and exercise to improve glycemic contrl in patients when stable dosage of insulin and metformin alone do not provide adequte control. for the treatment of hypotrichosis of the eye-lashes by Bimatoprost Eye Drps increasing their growth including length, thickness & 0.1mg/ml darkness. S(+) Etodolac 5/10%w/w + Camphor 4%w/w + Menthol For the painful & inflammatory conditions associated 10%w/w + Methyl salicylate with joint, tendons, ligaments and muscles 5%w/w + Linseed oil 3%w/w Cefpodoxime For the treatment of lower RI, Skin and soft tissue, 100/200mg+Dicloxacillin ER bone and joint infections and ENT infections in adult 500/500mg patients prone to antibiotic induced diarrhoea Voglibose0.3 + Metformin (SR) Additional higher strength 500mg

144

19/07/10

145 146 147

19/07/10 30/07/10 30/07/10

148

02/08/10

149

05/08/10

150

05/08/10

151 152

06/08/10 06/08/10

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in the treatment of infections due to susceptible strains of the designated micro-organisms in the condition of Amoxycillin Oral Suspension E.N.T infection, skin & skin structure infection, lower 09/08/10 200/400 mg per 5ml respiratory tract infection, genito-urinary tract infection, gonorrhea, acute uncomplicated (anogenital & urethral) infections. Additional indication: 1. For the treatmenmt of Olmesartan 40mg + hypertension alone or with other antihypertensive Amlodipine 5mg (Additional agents 2. To use as initial therapy in patients who are 09/08/10 Strength) likely to need multiple antihypertensive agents to achieve their blood pressure goals Complicated intra-abdominal infections and Doripenem 500 mg powder for complicated urinary tract infections, including injection (Additional 10/08/10 complicated and uncomplicated pyelonephritis and Indication) cases with concurrent bacteremia Nadolol tablet USP 20/40/80 in the treatment of angina-pectoris, cardiac arrythmias 20/08/10 mg & essential hypertension. Fluconazole For Oral for the treatment of systemic candidiasis, mucosal suspension 50/200 mg per 5ml candidiasis, prevention of fungal infections in patients 20/08/10 (Pack Size : 35ml) with malignancy. Indicated as an adjunct to diet and excersice to improve glycemic control in adults with type 2 diabetes mellitus Metformin 500/500mg + who are already treated with a meglitinide & 20/08/10 Repaglinide 1/2mg metformin or who have inadequte glycemic control on a meglotinide alone or metformin For management of pruritus due to allergic conditions Hydroxyzine Hydrochloride SR such as chronic urticaria and atopic contact dermatoses, 20/08/10 Tablets 25/50/75mg and in histamine - mediated pruritus. Rosuvastatin For the treatment of combined hyperlipidemia in 5/10/20mg+Fenofibrate 23/08/10 patients with normal hepatic and renal function 67/145/160mg Fexofenadine 120mg + For treatment of allergic rhinitis in adults only 31/08/10 Montelukast 10mg